MXPA01006168A - Method for alleviating female urinary incontinence - Google Patents

Abstract

A method for alleviating female urinary incontinence especially during episodes of increased intra-abdominal pressure is disclosed. The method includes the steps of providing a non-absorbent urinary incontinence device having an initial cross-sectional area, an insertion end and a trailing end. The urinary incontinence device also contains a compressed resilient member which is capable of increasing the cross-section area of the urinary incontinence device when expanded. The urinary incontinence device is inserted into a woman's vagina with the insertion end entering first. The vagina is a canal with an inner periphery made up of right and left lateral walls, an anterior wall and a posterior wall. The urinary incontinence device is inserted such that it contacts at least two of the walls. The urinary incontinence device is positioned in the middle third of the length of the vaginal canal with the insertion end aligned adjacent to a woman's urethral sphincter muscle. The urethral sphincter muscle is a part of the urethral tube. The urinary incontinence device cooperates with a woman's symphysis pubis to sandwich the urethral tube therebetween. The resilient member is allowed to expand within the vaginal canal such that at least a portion of the urinary incontinence device increases in cross-sectional area and contacts all four interior walls of the vaginal canal and provides a supportive backdrop for the urethral tube. The urethral tube is then permitted to be compressed upon itself between the urinary incontinence device and the symphysis pubis thereby limiting involuntary urine flow.

Description

METHOD FOR RELIEVING FEMALE URINARY INCONTINENCE FIELD OF THE INVENTION This invention relates to a method for relieving female urinary incontinence. More specifically, this invention relates to a method for alleviating female urinary incontinence during episodes of increased intra-abdominal pressure.

BACKGROUND OF THE INVENTION Some women, especially women who have given birth to one or more children, and older women, may experience incidences of involuntary urine leakage due to the stress of urinary incontinence or a combination of pressure and effort incontinence. A sneeze or cough can increase intra-abdominal pressure by hitting a person's bladder and causing an involuntary release of urine. The frequency and severity of such urinary loss may increase as the muscles become weaker and weakened near the urethrovaginal myofascial area. It has been recognized that the urinary sphincter muscle, which is located in the upper extremity of the urethra on one side of the bladder, works well to seal the passage of urine from the bladder to the urethra when it has a cross-sectional configuration Round circular. However, when this duct is distorted into a cross-sectional configuration that has more elliptical or oval appearance, the sphincter muscle can not close properly, and therefore there is a tendency for increased involuntary urine loss.

As the female population of the world ages, there is an ever-increasing need for a n surgical procedure to reduce the involuntary urine loss commonly associated with "urinary stress incontinence". Currently, there are a number of products available for this purpose. Essentially all of these products can only be purchased with a prescription and these require that they be physically inserted and / or adjusted by a doctor, physician or nurse practitioner in order to function properly. Currently, there are no commercially available products, if a prescription, to prevent the loss of urine involuntari by stress urinary incontinence.

In view of the lack of commercially available non-prescription urinary incontinence devices, it is recognized that there is a need for a urinary incontinence device which can be purchased without a prescription. There is also a need for a device for urinary continence which is not complicated and therefore more friendly and can be handled by the consumer without the intervention of a medical practitioner. In addition, there is a need for a device for urinary incontinence which is easy to insert and remove from the bodies of women, which is more comfortable to use and which provides a physiological and realistic confidence that it is capable of functioning properly on a extended period of time.

By having a method available to alleviate female urinary incontinence, especially during episodes of increased intra-abdominal pressure, women will be able to better manage this problem.

SYNTHESIS OF THE INVENTION Briefly, this invention relates to a method for alleviating urinary incontinence in women especially during episodes of increased intra-abdominal pressure. The method includes the steps of providing a non-absorbent urinary incontinence device having an initial cross-sectional area, an insertion end and a tail extremity. The device for urinary incontinence also contains a compressed elastic member which is capable of increasing the cross-sectional area of the device for urinary incontinence when it expands. The device for urinary incontinence is inserted into the vagina of a woman with the insertion end coming in first. The vagina is a cana with an inner periphery made of the left and right side walls, an anterior wall and a posterior wall. The device for urinary incontinence is inserted so that it makes contact with at least two of the walls. The next step is to place the device for urinary incontinence in the middle third of the total length of the vaginal canal with the insertion end aligned to a line of the urethral sphincter muscle of the woman. The urethral sphincter muscle is part of the urethral tube. The device for urinary incontinence cooperates with the pubic symphysis of the woman to sandwich the urethral tube between them. The elastic member is allowed to expand within the vaginal canal so that at least a portion of the device for urinary incontinence increases in the cross-sectional area and makes contact with all four interior walls of the vaginal canal and provides a backdrop for the vaginal canal. support for the urethral tube. The urethral tube is then allowed to be compressed on itself between the device for urinary incontinence and the pubic symphysis, limiting both the flow of involuntary urine.

The general object of this invention is to provide a method for alleviating women's urinary incontinence. More specifically, this invention relates to a method for alleviating urinary incontinence in women during episodes of increased intra-abdominal pressure.

A more specific object of this invention is to provide a method for alleviating female urinary incontinence during episodes of increased intra-abdominal pressure where a nonabsorbent device is placed in a woman's vagina and provides support to a woman's urethra. The woman to avoid involuntary urine loss commonly associated with stress urinary incontinence.

Another object of this invention is to provide a method for alleviating women's urinary incontinence using a device which is simple to use, easy to insert and remove, and which is convenient to use.

A further object of this invention is to provide an efficient and economical method for alleviating female urinary incontinence.

Yet another object of this invention is to provide a method for alleviating urinary incontinence of a woman who uses a device which can be purchased by a consumer without a prescription.

Still further, an object of this invention is to provide a method for alleviating women's urinary incontinence without interrupting the availability of normal vaginal secretions which are necessary for a healthy vaginal ambient.

Other objects and advantages of the present invention will be more apparent to those skilled in the art in light of the following description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a middle sagittal section of a human torso showing a device for urinary incontinence placed in the vaginal canal and cooperating with the pubic symphysis to allow the urethral tube to be compressed on itself and relieve urinary incontinence during episodes. of increased intra-abdominal pressure.

Figure 2 is a sectional view taken along line 2-2 of Figure 1 showing the relaxed cross-sectional configuration of the vaginal canal and urethra.

Figure 3 is a side view of an incorporation of a gentle wind having a d-shaped part dome.

Fig. 4 is a side view of a soft wind shown in Fig. 8 after a device for urinary incontinence has been compressed and after which a withdrawal cord has been fastened.

Figure 5 is a top view of the urinary incontinence device shown in Figure 4 taken along line 5-5.

Figure 6 is a side view of the device for expanded urinary incontinence.

Figure 7 is a side view of a device for urinary incontinence housed in an applicator.

Figure 8 is a flow diagram of a method for relieving women's urinary incontinence.

DETAILED DESCRIPTION OF THE PREFERRED INCORPORATIONS Referring to Figures 1 and 2, there is represented a human torso 10 of a woman showing vagina 12, a cervix 14, a uterus 16, an urethra 18, a vejig 20 and a pubic symphysis 22. The vagina has an introital opening 24 which leaves the human body 10 and contains a vaginal canal 26 which extends from the introite opening 24 to the cervix 14. The vaginal canal 26 has a length 1 which varies from about 4 inches to about 6 inches (around 102 millimeters (mm) to around 15 millimeters) in most women. The cervix 14 is the entrance to the uterus and is located between the upper aspect of the vaginal canal 26 of the uterus 16. The vaginal canal 26 has an inner periphery 28. The inner periphery 28 is made of the right and left side walls, 30 and 3 respectively, an anterior wall 34 and a posterior wall 36. The anterior wall 34 is located as close to the urethra 18 and the urethra 18 is located between the pubic symphysis 22 the vagina 12. The vaginal canal 26 can be divided into three sections about the same, each representing one third of the overall length. Each section is approximately 2 inches (approximately 51 millimeters (mm)) in length. The middle third of the vaginal canal 26 is the most important section for relieving urinary incontinence in women due to its proximity to the urethra 18 and is the location where a device for urinary incontinence should be placed. The middle third of the vaginal canal 26 is also decentralized horizontally from the pubic symphysis 22, which is a bony prominence located on one side of a frontal part 38 of the pubis of the human torso 10. The cooperation between the urinary incontinence device placed in the the middle third of the vagina 12 and the pubic symphysis 22 allows the urethra 18 to be compressed on itself to alleviate the flow of involuntary urine from the bladder 20.

The urethra 18 is a hollow tube 19 which extends from a first opening 40, which leaves the human body 10, to a second opening 42 located in the lower surface of the bladder 20. This urethral tube 19 has a length of about of 1.5 inches (about 3 millimeters) in most women. The urethra 18 functions to discharge the urine which is temporarily stored in the bladder 20 of the human body. The urethra 18 has a plurality of urethral sphincter muscles 44 located along the length of the inner periphery of the urethra tube 19. The sphincter muscles 44 are located below the aperture 42 and are ring-like muscles that normally maintain a constriction of the urethra. the urethra 18 to prevent the passage of urine through it. Relaxation of the sphincter muscle 4 by normal physiological functioning allows the urine to be expelled voluntarily from the human body.

Referring again to Figure 1, the human tors 10 also includes musculature and body tissue located in the urethrovaginal myofascial area 46 which is located between the vagina 12 and the pubic symphysis 22. The bladder 2 lies behind the pubic symphysis 22 and is separated from the rectum by vagina 12 and uterus 16. Uteruses (not shown) which carry urine from the kidneys (not shown) to vejig 20 pass from the pelvis to the posterior aspect of the urinary vejig 20. bottom of the bladders 48 within which both ureters run, is adjacent to the anterior wall 34 d of the vagina 12.

Referring to Figures 3-6, the method of relieving urinary incontinence in women especially during episodes of increased intra-abdominal pressure, includes providing a device for urinary incontinence n absorbent 50 which can be inserted into the vagina of a woman 12. The device for urinary incontinence 5 includes a non-absorbent 52 which can be constructed from materials that exhibit few, and preferably, no absorbent characteristics. The non-absorbent urinary incontinence device 46 differs from a catamenial plug in that it does not function to absorb body fluid. Instead, the non-absorbing urinary incontinence device 46 is designed to bridge the vagina 12 to support the musculature and body tissue located in the urethral vaginal myofascial area 46. By doing this, the urethra 1 can to be compressed on itself in a manner sufficient to intercept the flow of urine and can support the urinary sphincter muscle 44 so that it can function properly.

For the purposes of this invention an "absorbent n" is defined as a material which does not absorb significant amounts of moisture by itself. It must be recognized that virtually all materials will absorb some small amount of moisture. A fiber is considered to be non-absorbent for present purposes if it does not intrinsically gain more than about 6% by weight when a dry fibr is held at 21 ° C and 65% relative humidity for 24 hours. Non-absorbent materials include but nylons, scratches, spun cellulose, LYCRA®, KEVLAR®, carbon fibers and the like are not limited. The "LYCRA" and "KEVLAR" are E marks. I. D Pont de Nemours & Company which has an office at 100 Market Street, Wilmington, Delaware 19801. One such n absorbent 52 is a woven fabric made of bicomponent fibers which are commercially available from Chisso Corporation which has an office at 1411 Broadway, 35th Floor, New York, New York. Such fibers are sold under the name "Fibra d Bicomponent Chisso ESC" and consist of a polypropylene core surrounded by a polyethylene sheath. Fibers that work well have a denier of 3 and are 38 millimeters long. Other bicomponent fibers made of polyethylene polypropylene, etc. They are commercially available from their suppliers such as Exxon and Dow Chemical as well as from other vendors.

Alternatively, the non-absorbent 52 may be an absorbent material such as a rayon / cotton blend which has been chemically treated with a surfactant to make it n absorbent. However, truly non-absorbent fiber composite materials work well.

Referring to Fig. 3, the urinary incontinence device 46 is shown as a soft wind 54 which has been folded over itself at a point 56. The soft wind 54 includes the non-absorbent 52 and an elastic member 58. The member elastic 58 may be non-absorbent or at least partially absorbent of body fluids. However, there is no functional advantage to making the elastic member absorbent because the urinary incontinence device 50 does not function in a similar manner as the catamenial plug does. In fact, the device for urinary incontinence 50 works completely differently from that of a catamenial absorbent cap.

The elastic member 58 can be made from a natural or synthetic material which has the ability to recover quickly or return approximately to its original form and / or dimension. Such a change in elastic member 5 can be created by changes in intra-abdominal pressure with a result of laughing, sneezing, coughing or the like. An elastic material is a material which can return to resume its original shape or position after being folded, stretched or compressed. The elastic member 58 should also exhibit elasticity and flexibility so that it can be stretched or compressed and still retain the ability to return to its original or initial shape approximately.

Two natural materials of which the elastic member 58 can be formed include natural rubber and wool. The number of synthetic materials of which the elastic member 58 can be formed is much greater. Synthetic materials which may be used include: polyolefins, polyurethanes, polyethylene oxide (PEO), polyvinyl alcohol (PVA) as well as mixtures thereof. The elastic member 5 can also be formed of constructed elastic fibers, polyolefin-based fiber, polyethylene oxide fibers, hydrophobic rayon fibers and the like, which preferably will have characteristics similar to those of an elastic foam. In addition, the elastic member 58 can be formed from either an open cell foam or a closed cell foam.

The elastic member 58 can be made from a wettable spum. An open cell foam which works well has good elastic properties is commercially available under the brand ACQUELL®. The product "ACQUELL" is sold by Sentinel Products Corporation which has an office located at 70 Airport Road, Hyannis, Massachusetts 02601. A polyethylene closed cell foam that has good flexibility characteristics also works well. This foam is sold commercially under the brand VOLARA®. Said "VOLARA" is available from Voltex, a Division of Sekisui America Corporatio that has an office located at 100 Shepard Street, Lawrence Massachsetts 01843.

The elastic member 58 must also be capable of having what is known as "wet dry" expansion characteristics. In other words, the elastic member 58 must be made of a material which is capable of expanding or contracting back to its original or initial configuration in a dry state in a wet state or in a semi-dry and moist state. The dry expansion of the urinary incontinence device 50 is beneficial in the sense that the device does not have to be moistened by the body fluid before the elastic member 58 is able to expand within the vagina.

In Figure 3, the elastic member 58 is represented as a narrow strip of material which is rectangular in cross section. However, the elastic member 58 may have a square configuration, circular oval, or any other configuration in desired cross section. Preferably the elastic member 58 will have a uniform thickness and width. If desired, the dimensions of elastic member 58 do not have to be uniform. The narrow pull of the elastic material 58 can have a length 1 which is less than the length of the non-absorbent 52. The length of the elastic member 58 can be less than about 7 percent (%) of the length of the non-absorbent 52. Preferably length of the elastic member 58 is less than about 50% of the length of the non-absorbent 52, and more preferably, the length of the elastic member 58 is less than about 40% of the length of the non-absorbent 52. However, the length of the elastic member 58 may be equal to the length of the non-absorbent member 52 if so desired. The elastic member 58 also has a width which can vary from about .25 inches (about 6.4 millimeters) to about 1.5 inches (about 38.1 millimeters), preferably between about .5 inches (about 12. millimeters) and about 1 inch (about 25 millimeters), and more preferably about 1 inch (about 25.4 millimeters). The elastic member 58 has a thickness which may vary between about .1 in. (about 2.5 millimeters) to about 1 inch (about 25.4 millimeters), preferably less than about. inches (about 12.7 millimeters) and more preferably, d less than about .4 inches (about 10 millimeters).

When the elastic member 58 has a round or circular cross-sectional configuration, the diameter may vary from about .25 inches (about 6.4 millimeters) to about 1.5 inches (about 38. millimeters) preferably from between about. 2 inches (about 6.4 millimeters) to about 1 inch (about 25.4 millimeters) and more preferably less than about .5 inches (about 12.7 millimeters). For particular cross-sectional shapes such as an oval, a 2-lobed shape or a 3-lobed shape, an ellipse, etc., the largest dimension should not be larger than about 2 inch (around 50 millimeters).

Still referring to Figure 3, the soft wind 54 may contain a liquid permeable or liquid impermeable cover 60. The cover 60 is an optional element and n requires being present to form the device for urinary incontinence 50. However, the cover 60 can provide a smooth outer surface which may or may not be chemically treated to facilitate insertion and / or removal inside and outside a woman's vagina. When present, the cover 60 should have a length which is equal to or greater than the length of the non-absorbent 52. The cover 6 should have a width which is greater than the width of the absorbent n 52. The purpose of the larger dimension for the width it is that it allows the cover 60 to be bent over itself and to be joined to itself by heat, pressure, a combination of heat and pressure or by some other conventional means known to those skilled in the art. . If the cover 60 is formed of a material which does not readily attach itself, an adhesive, rubber or other attachment or fastening means may be used. If desired, the cover 60 can simply be folded over itself.

The cover 60 may be either liquid permeable or liquid impervious. When the cover 60 is impervious to liquid, this serves to block the body fluid from contacting the non-absorbent 52. Since the non-absorbent 52 is not designed to absorb any body fluid, it is not necessary for the cover to be impermeable to liquid. Liquid permeable materials include woven and nonwoven materials that have a porous substrate. Woven materials include textile fabrics which may be made of rayon, cotton or polyolefins. Polyolefins can be either basic or continuous filaments. Nonwoven materials may include spunbond, carded and bound fabrics and hydroentangled fabrics. Spunbonded and bonded woven fabrics are commercially available from Kimberly-Clark Corporation which has an office at 401 North Lake Street, Neenah, Wisconsin 54956. Another non-woven material which can be used as the cover 60 is formed from fibers of 100% polyester held together by a binder. This material is known as a charity fabric and a powdery substance (PBCW). The carded and bonded fabric is commercially available from HDK Industries Inc., which has an office at 304 Arcadia Drive, Greenville, South Carolina 29609 The cover 60 can also be constructed of liquid impervious material. A good liquid impervious material is a micro-etched polymeric film, such as polyethylene or polypropylene. The bicomponent films can also be used. A preferred liquid impervious material is a polyethylene film. The thickness of the cover 60 can vary from from about .1 millimeter to about 5 millimeters, preferably less than about .5 millimeters and more preferably less than about .2 millimeters.

Figure 3 represents an embodiment for smooth wind 54. It should be noted that soft wind 54 can have 2 or more bends and can be constructed of 2 or more layers if desired. The gentle wind 54, after being bent should have a length of from about 1 inch (about 25 millimeters) to about 3 inches (about 76 millimeters). A length of from about 1.5 inches (about 33 millimeters) to about 2.5 inches (about 63 millimeters) is preferred. The gentle wind 54 contains an insertion end 62 and a tail end 64. The elastic member 58 should be located at least partially at the insertion end 62 as to allow this end to expand once the incontinence device is in place. urinary 50 is placed inside the vagina 12 of a woman. The purpose of the elastic member 58 is to expand and force the insertion end 62 up and / or outwardly so that the user can make a pass through the cross-sectional area of the user's vagina and make contact with the user. the walls 30, 32, 34 and 36 of the vaginal canal 26. This action will retain the device for urinary incontinence 50 in a proper alignment with the vagina 12 and will create a force (pressure) which will help to support the surrounding tissue located in the area vaginal urethral myofascia 46. This action will also allow the transmission of a sufficient pressure through the urethra 18 to interrupt the flow of involuntary urine when the intra-abdominal pressure is raised. Because of this, the elastic member 58 does not necessarily have to extend through the entire length of the soft wind 58. The strength of the elastic member 58 will also dictate the size and shape necessary to properly open the insertion end 62. Depending on the material from which the elastic member 58 is constructed, and advantageous to employ an elastic member 58 which has a length which extends through the full length of the insertion end 62. The elastic member 58 will ensure that the smooth wind 54 will open enough once it's placed inside a woman's vagina.

Referring to Figures 4 and 5, the gentle wind 54 is then compressed in the urinary incontinence device 50. The urinary incontinence device 5 can have any desired shape but preferably, it will have a generally cylindrical shape with an e-section configuration. circular cross An alternative profile will be of a rectangular cross section configuration. The device for urinary incontinence 50 is represented as an elongate member having a length L, a width W and a depth D, see figure 5. When the device for urinary incontinence 50 is round in cross section, s diameter will be equal at width W and depth D. The length L of the urinary incontinence device 50 can vary from about .4 inches (about 10 millimeters) about 4.7 inches (about 120 millimeters preferably from about 1.5 inches). (around 38 millimeters) to about 2.5 inch (about 64 millimeters), and more preferably, the length L is at least about 2 inches (about 5 millimeters). The width W and the depth D can vary from between about .2 inches (about 5 millimeters) about 2.5 inches (about 64 millimeters) preferably from about between about .5 inches (around 12.7 mm) to around 2.3 inch (around 60 mm). More preferably the width W the depth D of the device for urinary incontinence 50 is less than about 1.6 inches (about 4 millimeters).

The insertion end 62 is designed to be the first part of the urinary incontinence device 50 that enters the vagina 12 of the woman. It should be noted that, while in use, the urinary incontinence device 50 will be placed completely inside the vagina 1 of the woman. Since the insertion end 62 contains the bent tip 56, it will normally contain a quantity of nonabsorbent material greater than the tail end 64. Even though a larger amount of nonabsorbent 52 may be present at the insertion end 62, the The outer diameter of the insertion end 62 must be equal to the outer diameter of the tail end 64. The amount of the non-absorbent material at the insertion end 62 will have to be densified to a greater extent than the non-absorbent material constituting the tail end. 64. By having a larger amount of non-absorbent 52 present at the insertion end 62, the urinary incontinence device 50 is more able to expand and better support the musculature and body tissue located on one side of the urethra and to facilitate urethral compression. This will eliminate the involuntary escape of urine through the urethra 18.

When the urinary incontinence device 50 is formed, the elastic member 58, the non-absorber 52 and the cover 60, if present, are all compressed. The device for urinary incontinence 50 can be compressed radially and longitudinally or it can be compressed only in the radial direction. The elastic member 5 must be located at least at the end of the insert 62. The compression step must not have a detrimental effect on the function of the elastic member 58. In other words, the elastic member 58 must be able to expand outwardly. Make your original or initial configuration once the urinary incontinence device 50 has been inserted into the vagina 12 of the woman. The elastic member 58 must be capable of expanding to at least a portion of the urinary incontinence device 50 to provide support for a woman's urethra 18 when properly inserted and placed in the vagina 12 of a woman.

Still referring to Figure 4, the device for compressed urinary incontinence 50 is drilled near its tail end 64 to form an opening or hole 6 which extends partially or completely therethrough. The opening 66 can be formed perpendicular to the central longitudinal axis X-X or at an angle thereto. Preferably, the opening 66 is spaced by a short distance from the actual end 64. The opening 66 may be located at a distance of between about .1 in. (around 2.5 millimeters) to around .5 inch (about 12.7 mm) from the end 64. Preferably, the opening 66 is located at about .25 inches (about 6.4 mm) from the tail end 64. The bore 66 is designed to allow s to place a rope withdrawal 68 through it and securing the device for urinary incontinence 50. The withdrawal cord 68 should help remove the device for urinary incontinence 50 from vagina 12. Perforation 6 can be formed with a needle, a punch or some other type of piercing device known to those skilled in the art. The withdrawal cord 68 is threaded through the opening 66 to secure itself as to securely cinch it to a urinary incontinence device 50. The free ends of the withdrawal cord 68 is then tied at a nud 70 to ensure that the withdrawal cord 68 will not be separated from the urinary incontinence device 50. The knot 7 also serves to to prevent wear of the withdrawal rope 6 and to provide a place or point where a woman can grab the withdrawal rope 68 when she is ready to remove the urinary incontinence device 50 from her vagina 12.

It should be noted that the withdrawal rope 68 limits the amount by which the tail end 6 will expand while the urinary incontinence device 5 is placed inside the vagina 12. It should be noted that the withdrawal rope 68 can be secured and / or fastening to various area of the urinary incontinence device 50 and can pass through one or more of the elastic members 58, of the absorbent n 52, of the covers 60, if present or through the 3 members if desired The perforation 66 may alternatively form in the gentle wind 54 before it is compressed and the withdrawal rope 68 may be attached either before the soft wind 54 is compressed or after the gentle wind 5 is compressed in the device for urinary incontinence 50 The withdrawal rope 68 can be constructed of various types of threads or tapes. A thread or ribbon made of 100% cotton fiber works well. The withdrawal cord 68 must have a length which extends beyond the end of the urinary incontinence device 50 from between about 1 inch (about 51 millimeters) to about 8 inch (around 203 millimeters), preferably from about 4 inches (about 102 millimeters) to about 6 inches (about 152 millimeters), and more preferably, about 5 inches (about 12 millimeters). The withdrawal cord 68 can be dyed and / or treated with an agent against the transmission, such as the wax, before being secured to the urinary incontinence device 50. The agent against transmission will be expected to reduce the delay. that the body fluids are transmitted from the withdrawal rope 68 and make contact with the inner surface of the woman's undergarment. A clean and dry drainage cord 68 is preferred by the user, especially when she is going to remove the device for urinary incontinence 50 from her vagina 12.

Referring now to Figure 6, the urinary incontinence device 50 is shown with the even end of the insert 62 expanded as will occur once the device 50 is inserted and placed inside the vagina 12 d the woman. The elastic member 58 has returned to its initial state and has caused the insertion end 62 to grow and expand upwardly and / or outwardly so that the urinary incontinence device 50 will be intimately contacted with all four walls 30. 32, 34 and 36 of the vaginal canal 26. In doing so, the urinary incontinence device 50 will occupy the hollow area in the entire transverse section of the vagina 12 in the position along the length of the vagina 12 where the device for urinary incontinence 50 was placed. This will help the anterior vaginal wall 34 to press against the bottom of the bladder 48 of the bladder 20. In addition, the position and proximity of the urinary incontinence device 50 within the vagina 12 will support the urethral sphincter muscle 44 and allow to function properly. In addition, the relative position and proximity of the urinary incontinence device 5 within the vagina 12 will provide a backdrop for supporting and cooperating with the pubic symphysis 22 so as to allow the urethra 18 to compress itself. It will be remembered that while the functions identified above are carried out the device for urinary incontinence 50, which is composed of an inert and biocompatible material will not attract the normal secretions of the body and therefore will facilitate the maintenance of a normal vaginal environment. .

Referring again to Figure 1, the device for urinary incontinence 50 is shown placed in the vagina 12 so that it is located in the middle third of the vaginal canal 26 and completely fills hollow volume in this place. In other words, the urinary incontinence device 50 occupies approximately the average inches (about 51 millimeters) of the vaginal canal 2 and provides a supporting backdrop for body tissue and muscles located in the vaginal urethro myofascial area 46 In this position, the device for urinary incontinence 50 will be aligned with the upper part of the urethra 18 and will provide a supporting support for at least half of the urethral tube 19 which has a length of approximately 1.5 inches. (Approximately 38 millimeters). During episodes of increased intra-abdominal pressure, the compression occurring in the urethro-vaginal myofascial area 46 between the pubic symphysis 22 and the device for urinary incontinence 50 allows the sphincter muscles 44 to acquire a more normal configuration. The sphincter muscles 44 will then operate properly and the urethral tube 19 will be able to be compressed on itself. These two functions help each other to relieve the involuntary flow of urine from the bladder 20 through the urethral tube 19 and the external opening 40.

Referring to Figure 7, the urethral incontinence device 50 is shown housed in an applicator 72. The applicator 72 will facilitate the insertion of urinary incontinence device 50 into the vagina 12 of a woman. The applicator 72 may be identical to a plug applicator if desired. The applicator 72 is shown as a 2-piece telescopeable applicator having a hollow outer tub 74 and a hollow inner tube 76. The urinary incontinence device 50 is placed inside the outer tub 74 so that the inner tube 76 which has The smaller diameter can be pushed against the tail end 64. This action will cause the urinary incontinence device 50 to be ejected from the outer tube 74. The applicator 72 can be constructed of paper, cardboard or plastic. An example of an applicator is taught in U.S. Patent No. 5,795,346 which was issued by Achter et al. On August 18, 1998 in which it was titled "PLUG THAT HAS A ELASTIC MEMBER". This patent is incorporated by reference and becomes part of this.

It should also be recognized that the device for urinary incontinence 50 can be inserted digitally into the vagina 12 of a woman if desired. For digital insertion, the woman will use one of her fingers.

Referring to Figure 8, the method for alleviating urinary incontinence in women includes the steps of providing and aligning the device for non-absorbent urinary incontinence 50 with opening 24 of the vagina 12 d the woman. It should be remembered that the elastic member 58 is in a compressed condition at that moment. For proper functioning of the urinary incontinence device 50, the elastic member 58 has to be located at least partially close to the insertion end 62. The urinary incontinence device 50 is then inserted into the vagina 12 of a woman with the insertion end 62 entering first. When inserted, the urinary incontinence device 50 will be in direct contact with at least two d of the four walls 30, 32, 34 and 36 which comprise the inner periphery 28 of the vaginal canal 26. Because of the vaginal canal 26 it is normally maintained in a folded state with a plurality of ridges, it is not very feasible for the urinary incontinence device 50 to fill the entire hollow volume. The device for urinary incontinence 5 is then placed in a third of the length of the vaginal canal 26 so that the insertion end 62 is aligned to one side of one of the urethral sphincter muscles which is located in the urethral tube of the urethral tube. the woman. In this position, the device for urinary incontinence 50 cooperates with the pubic symphysis 22 to have the urethral tube between them in the form of a sandwich. The method further includes allowing the elastic member 58 to expand within the vaginal canal 2 so that at least a portion of the urinary incontinence device 50 increases in the cross-sectional area and makes contact with the four interior walls. , 32, 34 and 36 of the vaginal canal 26 and thus provides a supporting backdrop for the urethral tube 19. Finally, it allows the urethral tube to be compressed on itself between the device for urinary incontinence 50 and the pubic symphysis 22 to thereby limit the flow of involuntary urine. The method can also include the step of removing the device for urinary incontinence 50 from the vagina 12 of the woman.

As mentioned above, the device for urinary incontinence 50 can be housed in an applicator 7 before use. The applicator 72 will help provide a comfortable insertion as well as retain the urinary incontinence device 50 in a compressed state until it is ready to be used. Once the device for urinary incontinence 50 is removed from the applicator 72 and inserted into the vagina 12 of a woman, the elastic member 58 will be able to expand to an uncompressed state. The elastic member 58 must be capable of expanding to about 25% of its compressed state, preferably up to about 50% of its compressed state, and more preferably up to about 100% of its compressed state.

Although the invention has been described in conjunction with several specific embodiments, it should be understood that many alternatives, modifications, variations will be apparent to those with an art skill in light of the foregoing description. Therefore, this invention is intended to cover all those alternative modifications and variations which fall within the spirit and scope of the appended claims.

Claims (20)

R E I V I N D I C A C I O N S

1. A method for alleviating urinary incontinence of the woman comprising the steps of a) providing a device for non-absorbing urinary incontinence having an initial cross-sectional area and an insertion end and a tail end, said device for urinary incontinence contains a compressed elastic member which is capable of increasing the cross-sectional area of the device for urinary incontinence when it expands; b) inserting said device for urinary incontinence in the vagina of a woman with an insertion tip entering first, said vagina having a vaginal canal with an inner periphery constituted of the right and left side walls, an anterior wall and a posterior wall, and said device for urinary incontinence makes contact with at least two of said walls; c) placing said device for urinary incontinence in a third of the length of the dich vaginal canal with said insertion end aligned to a lad of the urethral sphincter muscle of the woman which is part of the urethral tube of the woman, and said device for urinary incontinence, it cooperates with the pubic symphysis of the woman to have the urethral tube between them in the form of a sandwich; d) allowing the elastic member to expand within the vaginal canal so that at least a portion of said device for urinary incontinence increases in cross-sectional area and contacts all four interior walls of said vaginal canal and provides a cutaway. of support background for said urethral tube; e) allowing said urethral tube to be compressed on itself between said device for urinary incontinence and said pubic symphysis limiting po both the involuntary flow of urine.

2. The method as claimed in clause 1 further characterized because it comprises the removal of a device for urinary incontinence of said vagina.

3. The method as claimed in clause 1 further characterized by comprises the said device for urinary incontinence in one applied to facilitate insertion into the vagina of a woman.

4. The method as claimed in clause 3 further characterized in that it comprises allowing said elastic member to expand to a non-compressed state when it is removed from said applicator and inserted into the vagina of a female.

5. The method as claimed in clause 1 further characterized in that it comprises allowing the elastic member to expand up to about 25% of the compressed state.

6. The method as claimed in clause 1 characterized in that it further comprises allowing the elastic member to expand to about 50% of the compressed state.

7. The method as claimed in clause 6, characterized in that it also comprises allowing the elastic member to expand up to about 100% of its compressed state.

8. The method as claimed in clause 1 characterized in that it comprises the construction of a device for non-absorbent urinary incontinence of a biocompatible and inert material that does not attract or retain the normal secretions of the body.

9. The method as claimed in clause 1 further characterized in that it comprises constructing said device for non-absorbent urinary incontinence in an elongated member having a length of at least d about two inches.

10. A method to relieve urinary incontinence in women that includes the steps of: a) providing a device for nonabsorbent urinary incontinence having an initial cross-sectional area and an insertion end and a tail end, said device for urinary incontinence containing a compressed elastic member which is at least partially localized by of the insertion end and the quad is capable of increasing said cross-sectional area of said device for urinary incontinence when it expands; b) inserting said device for urinary incontinence in the vagina of a woman with an insertion tip entering first, said vagina having a vaginal canal with an inner periphery constituted of the right and left side walls, an anterior wall and a posterior wall, and said device for urinary incontinence makes contact with at least two of said walls; c) "placing said device for urinary incontinence in a third of the length of the dich vaginal canal with the insertion end aligned to one side of the woman's urethral sphincter muscle which is a part of the urethral tube of the woman, said device for urinary incontinence cooperates with a woman's pubic symphysis to have said urethral tube between them in the form of a sandwich; d) allowing the elastic member to expand within the vagina of the female so that at least a portion of said device for urinary incontinence increases in cross-sectional area and makes contact with all four inner walls of said vaginal canal and provide a supporting backdrop for said urethral tube, - e) allowing said urethral tube to be compressed on itself between said device for urinary incontinence and said pubic symphysis limiting po both the flow of involuntary urine.

11. The method as claimed in clause 10, characterized in that it comprises the removal of a device for urinary incontinence of the vagina.

12. The method as claimed in clause 10 further characterized in that it comprises constructing said device for non-absorbent urinary incontinence in an elongated member having a length of from about 2 inches to about 4 inches.

13. The method as claimed in clause 10 characterized in that said vaginal canal has a length of from between about 4 inches to about inches and said device for urinary incontinence is placed at the two middle inches.

14. The method as claimed in clause 10 characterized in that said urethra has a length of about 1.5 inches and said device for urinary incontinence provides a support curtain for at least half of this distance.

15. A method to relieve urinary incontinence in women that includes the steps of: a) providing a device for nonabsorbent urinary incontinence having an initial cross-sectional area and an insertion end and a tail end, said device for urinary incontinence contain a compressed elastic member which is capable of increasing dich area in cross section of said device for urinary incontinence when it expands; b) inserting said device for urinary incontinence in the vagina of a woman with an insertion tip entering first, said vagina having a vaginal canal with an inner periphery constituted of the right and left side walls, an anterior wall and a posterior wall, and said device for urinary incontinence makes contact with at least 2 of said walls; c) placing said device for urinary incontinence in a third of the length of the dich vaginal canal with said insertion end aligned with a lad of the urethral sphincter muscle of the woman which is a part of the urethral tube of the woman, said device for urinary incontinence it cooperates with the pubic symphysis of the woman to have the urethral tube between them; d) allowing said elastic member to expand within the vagina of the woman and make contact with all four inner walls of said vagina channel thus extending in the cross-sectional area of said vagina and providing support for the fundus of the vagina. the woman; Y e) allowing the urethral tube to be compressed on itself between said device for urinary incontinence and said pubic symphysis thus limiting the flow of involuntary urine.

16. The method as claimed in clause 15 characterized in that it comprises the removal of a device for urinary incontinence of the vagina.

17. The method as claimed in clause 15 characterized in that it comprises housing a device for urinary incontinence in an applicator to facilitate the insertion into the vagina of a woman.

18. The method as claimed in clause 17, characterized in that it comprises allowing the elastic member to expand to an uncompressed state when it is removed from said applicator and inserted into the vagina of a woman.

19. The method as claimed in clause 15 further characterized in that it comprises constructing said device for urinary incontinence in an elongated member having a length of about two inches.

20. The method as claimed in clause 15 characterized in that said urethra has a length of about 1.5 inches and said device for urinary incontinence provides a supporting backdrop for at least half of this distance. R E S U E N A method to relieve female urinary incontinence is described, especially during episodes of increased intra-abdominal pressure. The method includes the steps of providing a device for nonabsorbent urinary incontinence that has an initial cross-sectional area, an insertion end and a tail end. The device for urinary incontinence also contains a compressed elastic member which is capable of increasing the cross-sectional area of the device for urinary incontinence when it expands. The device for urinary incontinence is inserted into the vagina of a woman with the insertion end coming in first. The vagina is a cana with an inner periphery constituted of the right and left side walls, an anterior wall and a posterior wall. The device for urinary incontinence is inserted so that it makes contact with at least 2 of the walls. The device for urinary incontinence is placed in the middle third of the length of the vaginal canal with the insertion end aligned to one side of the woman's urethral sphincter muscle. The urethral sphincter muscle is part of the urethral tube. The device for urinary incontinence cooperates with the pubic symphysis of the woman to have a sandwich and urethral tube between them. The elastic member is allowed to expand into the vaginal canal so that at least part of the urinary incontinence device increases in the cross-sectional area and makes contact with all four inner walls of the vaginal tube and provides a cutaway. Support fund for the urethral tube. The urethral tube is then left to be compressed on itself between the device for urinary incontinence and the pubic symphysis, thus limiting the flow of involuntary urine.